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Adverse Event Report

ALLEGIANCE HEALTHCARE JACKSON PRATT DRAIN HUBLESS FLAT DRAIN   back to search results
Catalog Number SU130-1311
Event Date 12/12/1997
Patient Outcome  Required Intervention;
Event Description

Jackson pratt drain. When physician attempted to remove the drain, the tip broke off. Pt was returned to the or for removal of tip (20cm. Hubless flat drain).

 
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Brand NameJACKSON PRATT DRAIN
Type of DeviceHUBLESS FLAT DRAIN
Baseline Brand NameDRAIN, FLAT,10X4MM,PERFORATED
Baseline Generic NameWOUND DRAIN
Baseline Catalogue NumberSU130-1311
Baseline Model NumberSU130-1311
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE
120 raritan ctr parkway
edison NJ 08818
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE
120 raritan ctr parkway
edison NJ 08818
Device Event Key153641
MDR Report Key157695
Event Key148210
Report Number157695
Device Sequence Number1
Product CodeGCY
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/16/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/17/1998
Is This An Adverse Event Report? No
Device Operator Health Professional
Device Catalogue NumberSU130-1311
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/16/1998
Distributor Facility Aware Date03/10/1998
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer03/16/1998
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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